Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)

Comprehensive behavior intervention for tics (CBIT) is a first-line behavioral treatment for
individuals with tic disorders. However, the benefit of CBIT is mitigated in those with
co-occurring ADHD, as ADHD is negatively associated with effect size in behavioral treatments
for tics. Additionally, while tic disorders are associated with reduced quality of life
measures, CBIT is 'tic-specific.' Despite improving tics, measures do not show associated
improved quality of life. Currently, there are no standardized behavioral treatments for tics
that account for ADHD symptoms and/or address the impact that tics and ADHD symptoms have on
quality of life. The main purpose of this trial is to develop and then investigate the
effects of a modified comprehensive behavioral intervention for tics (CBIT) protocol for
children and adolescents with chronic tic disorders and ADHD.

Aim 1: Development a treatment protocol. The first aim is to develop a treatment protocol
that combines elements from CBIT, Cognitive Behavioral Therapy (CBT) for ADHD, and factors
targeting psychosocial impairment. A new treatment protocol, called "Living With Tics" was
recently developed by Dr. Eric Storch et al to help improve quality of life in those with tic
disorders. In addition to incorporating components of modules of the above listed treatments,
the modules themselves will be adapted to be more accessible to those with ADHD. As tic
disorders often have a significant impact on the family, the investigators will incorporate
parent involvement into the treatment as well.

Aim 2: Treatment Feasibility and Acceptability. The investigators' second aim is to determine
the treatment feasibility and acceptability of the developed protocol. They will examine the
retention rates, reasons for treatment refusal and dropout, and subject/parents motivation
for this modified CBIT treatment. They plan to evaluate and assess the randomization process,
the treatment modules, and the expectations and satisfaction of the participants and their
parents. They will use measures including expectancy and satisfaction scales, and Likert
scales will be provided at the end of each session to help determine which components of the
modules were most and/or least helpful. From those results, the investigators can continue to
adapt the treatment protocol for future, larger studies.

Aim 3: Pilot test the treatment's effectiveness. The final aim is to conduct a pilot
randomized control trial (RCT) to test the developed protocol in youth with tic disorders and
co-morbid ADHD. Half the subjects will undergo treatment with the modified protocol, and half
of the subjects will receive standard CBIT treatment. A broad range of outcome measures will
be used to evaluate tic symptoms, ADHD symptoms, and quality of life, and predictors of
treatment response will be explored. The following scales will be used: Yale Global Tic
Severity Scale (YGTSS), NICHQ Vanderbilt Assessment Scales, and Pediatric Quality of Life
Inventory-Child Version (PedsQL) scale, as rated by a blinded clinician. Additionally, the
investigators will compare which components were most/least helpful to subjects. Though the
investigators will evaluate efficacy of the modified protocol, the primary purpose will
remain feasibility. The investigators hope to use this study to develop larger randomized
controlled trials in the future.

The modified CBIT treatment will be based on the original CBIT protocol developed by Dr. John
Piacentini et al in 2010, a CBT for ADHD in adolescents protocol recently developed by Dr.
Susan Sprich et al, and Dr. Eric Storch's "Living with Tics" protocol. Techniques from other
studies, which combined and adapted protocols will be incorporated as well.

The treatment will be divided into three phases: Evaluation/Psychoeducation, Basic
Intervention, and Relapse Prevention, with a total of 12 sessions.

Prior to beginning the treatment, to make sure the subject qualifies, parent(s) and subject
will be asked to come in to complete a baseline assessment component.

Evaluation/Psychoeducation (Sessions 1-2): The first 1-2 sessions will focus on assessing the
subject's tics and ADHD symptoms, and assessing the impact of tics and ADHD on the subjects'
lives. Psychoeducation about tics/Tourette Syndrome and ADHD, and the CBIT and CBT models
will be provided. The therapist will create a hierarchy with the patient regarding which tics
are most bothersome and what other symptoms/stressors are most impactful on everyday life.
Planning and organizing skills and the idea of function-based interventions will also be
introduced. Participants will be encouraged to bring their parent(s) to these initial
assessment sessions to familiarize the parent(s) with the treatment methods and allow them to
ask questions about tics and ADHD and/or the intervention. If appropriate, parents will be
involved in the treatment or homework procedures, but this will vary depending on the comfort
level and potential benefit as assessed for each child.

Basic Interventions (Session 3 to Session 10): Beginning in Session 3, basic CBIT, cognitive
and behavioral methods will be taught during office sessions and assigned as homework
throughout the treatment. In addition to including modules that will specifically target ADHD
symptoms (such as those on organization and planning and distractibility), modules in general
will be designed to target an ADHD population. Modules will include a combination of activity
schedules, positive reinforcements to promote on-task behavior, short "brain breaks" in
between activities, repetition of key concepts, and the use of visual aides during the
sessions and between sessions at home. Handouts describing the topics covered will also be
provided to the parent/patient at the conclusion of each session. Relaxation techniques will
be incorporated. Some adapted modules from "Living with Tics" will be included depending on
the patients' identified difficulties.

Relapse Prevention (Sessions 11-12): The final sessions, each spaced two weeks after the last
session, will focus on relapse prevention. The purpose of the spaced sessions in to allow the
patient to get more practice and learn to be their own therapist in between meetings.
Residual problems and fears about ending treatment will be addressed, and unrealistically
optimistic or pessimistic thoughts about treatment termination will be challenged. Patients
will learn to anticipate possible symptom recurrence and its relationship to stress, mood,
and other factors; counter negative thoughts about setbacks; and handle lapses and setbacks.
Parents will also be encouraged to attend the last session(s) if the child/adolescent or
clinician feels it would be appropriate.

Inclusion Criteria:

1. Have a DSM-5-based diagnosis of Tourette Syndrome or Persistent Motor or Vocal Tic
Disorder

2. Have a diagnosis of ADHD by DSM-5 standards, or a previous diagnosis of ADHD where
there are some residual symptoms (at least 7/18) but does not currently meet
diagnostic criteria due to current medications.

3. Tic disorder is the most problematic psychiatric disorder and the primary reason for
seeking treatment

4. Have a current total tic severity score of >13 (or >9 if CTD) on the Yale Global Tic
Severity Score (YGTSS), and a current total impairment score of >19 on the YGTSS

5. Be male or female and between 10-17 years of age at the start of the treatment,
inclusive

6. Be able to communicate meaningfully with the investigators and be competent to provide
written assent; both parental informed consent and adolescent assent must be obtained

7. Be English speaking

Exclusion Criteria:

1. Comorbid psychiatric diagnoses including: alcohol or substance abuse or dependence
within the past 3 months, psychosis, organic mental disorder, current mania,
developmental delay, estimated IQ <80 on the Wechsler Abbreviated Scale of
Intelligence (WASI), other cognitive impairment that would interfere with ability to
engage in CBT, or other developmental/cognitive impairment that precludes the
participant from being able to communicate meaningfully with the treater

2. Those deemed to pose a serious suicidal or homicidal threat (e.g., suicide attempt
within past 6 months and/or endorsement of "I want to kill myself" on the Children's
Depression Inventory (CDI)).

3. Current illness (tics or otherwise) so severe that an immediate psychopharmacological
evaluation is warranted

4. Any clinical features requiring a higher level of care than outpatient (as determined
by evaluator).

5. Intent to travel for a period longer than two weeks (such that three sessions would be
missed) during the proposed time-frame of the study. However, this criterion may be
waived as per the discretion of the Principal investigator.

6. In general, the participant cannot be engaged in concurrent psychotherapy - if they
are, they would need to stop (no lag time required between stopping current therapy
and beginning this intervention). Decisions can be made on a case by case basis if the
therapy is for a concern/disorder separate from mood, anxiety or OCD-spectrum
disorders (e.g. gender dysphoria).

7. Four or more sessions of previous CBT treatment similar to the current treatment (CBIT
and/or CBT for ADHD) within the last five years

8. Participants can be receiving psychotropic medication, but they must be on a stable
dose for four weeks prior to the study baseline assessment and maintain this dosage
throughout the course of the study. If a potential participant is taking psychotropic
medication at the time of the phone evaluation or the first in-person study assessment
and wishes to discontinue this medication to enter the trial, the participant will be
asked to discuss this option with their prescribing physician to determine whether
medication discontinuation would be safe and in the participant's best interest. We
will not influence the decision or procedures participants choose with their
prescribing physician. If the participant decides to discontinue treatment with the
psychotropic medication, he/she must wait for four weeks before receiving a baseline
assessment.